Intal n dosieraerosol, 2x10 ml

Upute za korištenje Intal n dosieraerosol, 2x10 ml

Important notes (compulsory information):

Intal N aerosol 1 mg / 1hub, compressed gas inhalation, suspension active ingredient: sodiumcromoglicat (pH. EUR.) * Areas of application: For the prevention of asthmatic complaints with light persistent (persistent) allergic and non-allergic asthma (level 2 of the asthma stage scheme).
*With sodium scrimoglicat (ph.eur.) Is the disodium salt of the cromoglicic acid.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


LEAFLET: INFORMATION FOR THE USER

Intal N Aerosol 1 mg / 1hub, compressed gas inhalation, suspension
Active substance: Sodiumcromoglicat (Ph. EUR.)*

Read the entire leaflet carefully because it contains important information for you. This medicine is also available without prescription. However, in order to achieve the best possible treatment success, Intal N Aerosol must be used properly.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• The asthma treatment should always be in consultation with your doctor.
• If your complaints worse or no improvement occurs, you must definitely visit a doctor.
• If one of the listed side effects you significantly affect it or notice side effects that are not specified in this information information, please inform your doctor or pharmacist.

This leaflet contains:

1. What is Intal N aerosol and what is it used for?
2. What do you need to consider before using Intal N Aerosol?
3. How to use Intal N Aerosol?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How to keep Intal N aerosol?
6. ADDITIONAL INFORMATION

1. What is Intal N aerosol and what is it used for?

Intal N aerosol is a medicine for prevention of asthmatic complaints. Intal n aerosol is applied to the prevention of asthmatic complaints with a light persistent (persistent) allergic and non-allergic asthma (level 2 of the asthma stage scheme). Note: Intal N aerosol is not suitable for the treatment of acute asthma attack.

2. What do you need to consider before using Intal N Aerosol?

Intal N aerosol must not be used if it is hypersensitive (allergic) against sodium cromoglicat (ph.eur.) or one of the other ingredients of Intal N aerosol are.

Take special care with Intal N aerosol is required:
Asthma therapy should be carried out as a grave degree accordingly. The success of the treatment should be due to regular medical examinations and through a daily self-control (eg by the recording of the breath-flow meter measured at the peak flow meter) checked. Intal N aerosol is not suitable for the treatment of acute asthma attack. As with other inhalation treatments, it can be directly after the inhalation into a paradoxical spasm of bronchial muscles (bronchospasm) come. In such cases, the medicine should be discontinued and an alternative treatment should be carried out. In the event of eosinophilic pneumonic infiltrates (certain form of pneumonia) under sodium cromoglicat therapy, it must be discontinued immediately. During sudden discontinuation of Intal N aerosol, it can be deteriorated to the basic suffering. The discontinuation should take place after consultation with the attending physician through a gradual dose reduction over a week.

Children:
In children, regular checks of the course of the disease are particularly important to ensure that Intal N aerosol is sufficiently effective. When using Intal N Aerosol with other medicines, please inform your doctor or pharmacist if you take / use other medicines or recently taken / applied, even if it is not prescribingmedicinal products.
Interactions with other medicines are not known.

Pregnancy and breast feeding period:
Indications for a frustrated effect of Intal N aerosol are not available from animal studies as well as from the experiences of people's experience. Nevertheless, you should only use Intal N Aerosol from fundamental considerations during pregnancy if the doctor is required for it. It is not known if the active ingredient transitions from Intal N aerosol into breast milk. Therefore, you should only use Intal N aerosol during breastfeeding when the doctor is required for it. Ask your doctor or pharmacist for advice before taking / application of all medicines.

Driveion and use of machines:
There are no special precautions required.

3. How to use Intal N Aerosol?

Always use Intal N Aerosol exactly as your statement in this leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by the doctor, the usual dose is: At the beginning, a 4-time daily application is useful. The stated daily doses can be doubled, the application frequency will be increased to 6 times a day. After reaching the therapeutic effect, the dosage intervals can be gradually extended to the amount required to maintain the symptom freedom. In asthma therapy, sodiumcromoglicat is only suitable for prevention of asthmatic complaints, but not for therapy acute asthma attacks. A test dose should be given at least for 4 weeks. The full effect is generally after 2 - 4 weeks. A gradual dose reduction over 1 week is recommended. Adults and children inhale 4 times a day each 2 strokes (1 stroke contains 1 mg of sodiumcromoglicat (ph.eur.)).

Type of application:
Intal N aerosol is intended for inhalation only for local application. Children should inhale Intal N aerosol only under supervision of adults. In order to achieve a better treatment result, special inhalation aids can be used when administration (eg Fisonair). Application in children can be done, provided that they are able to handle a dosing aerosol correctly (usually from the 5. Age). In order to achieve an optimal therapeutic effect, a detailed instruction of the patient is required in the use of these special devices. In children, it is particularly important to ensure that the inhalation device is suitable for the appropriate age.

Instructions for use for handling the dosing aerosol. Please note exactly.
Before the first application, please release 4 sprays in the air to make the dosing aerosol ready to use! If Intal N Aerosol was not applied for more than 2 days, the release of 4 spray sizes is enough to make the dosing aerosol ready to use.

The Intal N Aerosol Inhaler:

• Metal container with active ingredient
• white case with mouthpiece
• blue protective cap

1. Remove blue protective cap.
2. Shake inhaler with the floor up strong.
3. Exhale deeply. Do not breathe into the mouthpiece.
4. Clock the mouthpiece with the lips. Slowly and deep breath and at the same time press the metal container down so that a spray is released.
5. Take the mouthpiece out of the mouth. Pause for a few seconds. Then exhale slowly through the nose.
6. After about a minute, repeat the inhalation in compliance with points 3 to 5. Then place protective cap.

Important information on care and cleaning:
Intal N aerosol is a medicament preparation in which the active ingredient is in finely divided, solid form. Even with correct application, deposits in the plastic housing are inevitable. So that the dosing aerosol always works, the plastic housing must be kept clean by being cleaned every two to three days - best even daily. This prevents the dosage from becoming inaccurately or the spray opening clogged and therefore no longer can be released.

To clean the dosing aerosol, proceed as follows:

1. Remove the blue protective cap.
2. Remove the metal container out of the white plastic housing.
3. First rinse the plastic housing from above (side with the opening in which the metal container is inserted), then from below (Page to which the blue protective cap is placed) for a minute with handwarm water (about 45 ° C) to release deposits in the spray opening.
4. Remove excess water from the inside of the plastic housing by knocking it with the opening into which the metal container is inserted on a hard surface knock and let it dry well (e.g., overnight).
5. Make sure that the plastic housing is completely dry and that the rubber cuff is firmly seated on the metal container. Then put all parts together again, i. Plug the metal container back into the plastic housing, and reset the protective cap back onto the plastic housing.

Additional information:

• The rubber cuff on the metal container must not be removed because it is important for proper functioning of the dosing aerosol.
• Since the active ingredient contained in Intal N aerosol is water-proof, avoid storing the dosing aerosol in a humid environment to prevent gluing or clogging.
• If the dosing aerosol clogs, remove the blue protective cap and take the metal container out of the white plastic housing (see steps 1 and 2). Turn the plastic housing 20 minutes into hot tap water and repeat steps 3 to 5.
• Never try to eliminate a clogging of the dosing aerosol with a needle or similar objects. You would damage it.

Duration of application:
The use of sodium scrimoglicat for prevention of asthmatic complaints takes place as long-term therapy. Intal N aerosol can only act properly if it is used regularly according to the doctor's instructions or this leaflet. The duration of the usage will be decided by the medicating doctor. Please talk to your doctor or pharmacist if you have the impression that the effect of Intal N aerosol is too strong or too weak.

If you have applied a larger amount of Intal N aerosol than you should:
For sodium scrimoglicat poisoning phenomena are not known. If complaints suspected by an overdose of Intal N aerosol, a treatment directed against the complaints should be carried out.

If you forget the application of Intal N Aerosol:
Do not take the double dose if you forget the previous application. Please keep in mind that only a regular application leads to the desired effect.

If you cancel the use of Intal N Aerosol:
If you interrupt the treatment with Intal N aerosol, your complaints can deteriorate or occur again.

If you have further questions about the application of the medicine, ask your doctor or pharmacist.

4. Which side effects are possible?

Like all medicines, Intal N aerosol can have side effects, but they do not have to occur with each treated. The frequency information on side effects is based on the following categories:

The frequency information on side effects is based on the following categories:
Very often:	more than 1 treated from 10
Frequently:	1 to 10 treated from 100
Occasionally:	1 to 10 treated from 1 000
Rarely:	1 to 10 treated from 10 000
Very rare:	less than 1 treated from 10 000
Not known:	Frequency on the basis of the available data does not estimate.

Diseases of the nervous system:
Frequency not known: dizziness.

Diseases of the respiratory tract and the chest:
Very rare: Cramps of the bronchial muscles (paradoxical, transient bronchospasms), Eosinophilic pneumonia (pneumonia). FREQUENCY not known: irritation of the throat room, hoarseness, coughing.

Diseases of the gastrointestinal tract:
Frequency not known: nausea, unpleasant taste.

Skeletal muscles, bind geweb and bone disorders:
Frequency not known: muscle and joint pain.

Diseases of the immune system:
Very rare: severe allergic (anaphylactic) reactions with cramps of bronchial muscles (bronchospasms), low blood pressure (hypotension), circular failure (collapse) and swelling of the laryngeal mucosa (larynx edema). FREQUENCY not known: Hypersensitivity reactions: Hauverschlag, itching, hives (Urticaria), skin and mucous membranes (angioedema).

Please inform your doctor or pharmacist if one of the listed side effects will significantly affect it or notice side effects that are not specified in this document formation.

5. How to keep Intal N aerosol?

Store drug out of reach of children. You may post the medicine after the on the outer carton and the label "Usable until" stated expiry date no longer use. The expiry date refers to the last day of the month.
Storage conditions: Container is under pressure! Protect from heat, direct sunlight and frost! Do not spray on a naked flame or any incandescent material! Do not forcibly open or burn!

6. Further information

What Intal N contains aerosol:
The active ingredient is: sodiumcromoglicat (pH. EUR.). 1 stroke to 71 mg contains 1 mg sodiumcromoglicat (ph.eur.); This corresponds to one (Dose dispensed from the mouthpiece) of 0.95 mg of sodiumcromoglicat (Ph.eur.).

The other ingredients are:
Apafluran, Povidon K 30, Macrogol 600.

How Intal N Aerosol looks like and content of the pack:
1 Pressure container contains 10 ml of compressed gas inhalation, suspension (corresponding to 200 strokes). Intal N aerosol is in packs with 200 and 2 x 200 strokes available for inhalation.

Pharmaceutic entrepreneur:
Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main
Postal address:
Mailbox 80 08 60
65908 Frankfurt am Main
Telephone: (01 80) 2 22 20 10
Fax: (01 80) 2 22 20 10

Manufacturer:
Aventis Pharma Holmes Chapel
72 London Road, Holmes Chapel
Crewe, Cheshire CW4 8BE
England

This information information was last revised in June 2010.

Source: Information of the leaflet
Status: 01/2015